Duns Number:625272232
Device Description: One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection por One 200ml PVC processing bag, with a male luer, a female luer, a needle-free injection port and a spike port
Catalog Number
-
Brand Name
PVC Transfer Bag
Version/Model Number
10-200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK140116,BK140116,BK140116
Product Code
KSR
Product Code Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Public Device Record Key
9802efe5-ab71-4229-b125-bb16431de525
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
June 06, 2017
Package DI Number
20816203023272
Quantity per Package
24
Contains DI Package
10816203023275
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 44 |